Protocol: A Rapid Evidence Review of Retention Strategies for Medications for Addiction Treatment (MAT) in Adults with Opioid Use Disorder

Protocol: A Rapid Evidence Review of Retention Strategies for Medications for Addiction Treatment (MAT) in Adults with Opioid Use Disorder

Research Protocol

May 8, 2019

Review Questions

What is the effectiveness and comparative effectiveness of strategies (e.g., programs) to improve retention in medications for addiction treatment (MAT) among nonpregnant adults with opioid use disorder (OUD)?

Context

Because this is a rapid review, strategic adjustments will be made to streamline traditional systematic review processes in order to deliver an evidence product in the allotted time. We will follow adjustments and streamlining processes proposed by the US Agency for Healthcare Research and Quality Evidence-based Practice Center Program.1-4Examples of adjustments include narrowly focusing questions, limiting the number of databases searched and/or modifying search strategies, using a single reviewer and/or abstractor with a second to provide verification, and restricting to studies published in the English language.

Searches

We will search PubMed and the Cochrane Library for systematic reviews that address the research questions. If evidence gaps are identified, we will conduct follow-up searches of PubMed for primary studies.

Systematic reviews: PubMed and the Cochrane Library to be searched from 2009 onwards. We will conduct ad hoc searches of additional databases as needed.

Primary studies (if needed): PubMed. Search date will be based on evidence gaps.

Types of Studies To Be Included

We will assess systematic reviews based upon predefined inclusion criteria. Primary studies published in the last 10 years from included reviews, and any studies identified in subsequent searches, will be evaluated to see if these are applicable to our key questions. Because this review is being used to inform US decision-making, inclusion will be limited to studies published in English and conducted in countries classified as "very high human development" according to the United Nations Human Development Index.5

Systematic reviews:

Include: Reviews of reviews, systematic reviews, or rapid reviews. Reviews must search more than one database, pre-define their inclusion criteria, and conduct an assessment of study quality.

Exclude: Narrative reviews, editorials or commentaries.

Primary studies:

Include: Randomized controlled trials, and cohort or other observational studies that address key gaps in the trial evidence.

Exclude: Editorials, commentaries, or case series.

Condition or Domain Being Studied

Opioid use disorder (OUD) is an important public health issue. It is estimated that 2.1 million Americans 12 years or older met diagnostic criteria for OUD in 2017.6 Furthermore, in the U.S., 47,600 people died from an opioid overdose in 2017.7 In addition to overdose deaths, OUD is associated with markedly increased rates of comorbid conditions, including human immunodeficiency virus (HIV) and hepatitis C infections, and other substance use disorders.8

MAT currently refers to the three U.S. Food and Drug Administration approved medications for OUD- methadone, buprenorphine, and extended-release naltrexone.9 Prior systematic reviews of treatment studies have established that MAT significantly improves the outcomes of treatment for OUD.10,11 While strong evidence exists for the benefits of MAT, retention in MAT programs is highly variable, from 19% to 94% at 3 months.12 This rapid review, nominated by the Office of the Assistant Secretary for Health (OASH), Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), the Office of the Assistant Secretary for Mental Health and Substance Use for the Substance Abuse and Mental Health Administration (SAMHSA), the Division of Unintentional Injury Prevention in the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention (CDC), the Office of the Assistant Secretary for Planning and Evaluation (ASPE), the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA), will assist the US Department of Health and Human Services in US research, practice, and policy decision-making around strategies to improve MAT retention.

Participants/Population

Include: nonpregnant adults with OUD who are involved in MAT (buprenorphine, methadone, or naltrexone)

Comparator/Control

Setting

Out-of-hospital (community or outpatient)

Primary Outcome(s)

Treatment retention rates

Mortality

Harms

Functioning (e.g., physical and social)

Data Extraction (Selection and Coding)

Abstract and title review, full text review, and abstraction will be performed by one reviewer. A second reviewer will verify a 25% sample of articles and abstracted data. Disagreements will be resolved through discussion among the review team.

Risk of Bias (Quality) Assessment

Study quality will be assessed either by extracting systematic reviews' quality assessments, or by using a risk of bias tool based on criteria developed by the U.S. Preventive Services Task Force.13

Strategy for Data Synthesis

Data will be compiled into evidence tables and synthesized narratively. We will not conduct a meta-analysis or do a formal process to grade the strength of evidence.

Analysis of Subgroups or Subsets

As data are available and time allows, we will examine whether the effectiveness of the MAT retention strategies vary by patient characteristics (age, gender, socioeconomic status, geographic region, type or severity of opioid disorder).

External Peer Review

The protocol will be posted publicly. At least one content expert and one methodological expert will review the draft report. Potential Peer Reviewers must disclose any financial conflicts of interest greater than $5,000 and any other relevant business or professional conflicts of interest. Invited Peer Reviewers may not have any financial conflict of interest greater than $5,000. As time and situation allows we would also like to provide time for public comment on the rapid review at draft stage.

EPC Team Disclosures

EPC core team members must disclose any financial conflicts of interest greater than $1,000 and any other relevant business or professional conflicts of interest. Related financial conflicts of interest that cumulatively total greater than $1,000 will usually disqualify EPC core team investigators.

Role of the Funder

This project was funded under Contract No. HHSA290201700003C from the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. The AHRQ Task Order Officer reviewed contract deliverables for adherence to contract requirements and quality. The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Registration

This protocol will be registered in the international prospective register of systematic reviews (PROSPERO).